Kornimate/medical-research-clean huggingface dataset:
cosmetic outcome of electrocautery, scalpel and peak plasmablade for surgical breast incisions

Conditions: Wound Complication; Surgical Wound Infection; Post-operative Pain; Postoperative Complications; Scar

Summary: this study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (peak) plasmablade (ppb) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction. it is hypothesized that there will be no significant difference in mastectomy scar cosmesis. the purpose and objectives of this study are: 1. to evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or peak plasmablade for initial incision for total mastectomy procedures without immediate breast reconstruction. 2. to inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

scalpel, electrocautery, and peak plasmablade (ppb) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for ppb incision when compared to conventional electrocautery or scalpel. the investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or peak plasmablade. scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated scar-q questionnaire.

Eligibility criteria:
inclusion criteria: * patients having a total mastectomy with or without axilla surgical staging exclusion criteria: * patients having immediate breast reconstruction * patients with a diagnosis of inflammatory breast cancer * history of keloid scar formation * history of connective tissue disorder (scleroderma or rheumatoid arthritis with skin involvement) * patients with prior incision at the planned mastectomy site. * patients with known suture hypersensitivity * patients with evidence of current infection

Keywords: electrocautery peak plasmablade scalpel mastectomy incision
a phase i crossover study of the hemodynamic interactions of avanafil & alcohol in healthy male subjects.

Conditions: Erectile Dysfunction

Summary: the purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.

the trial is a single-centre double-blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 5 days between treatments: * treatment a: a single oral dose of one 200 mg avanafil tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight). * treatment b: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight). * treatment c: a single oral dose of one 200 mg avanafil tablet plus an oral dose of placebo drink mixed with fruit juice. for each treatment period, dinamap (or datascope) automatic measurements of supine blood pressure and pulse rate will be taken pre-dose and every 15 minutes for 4 hours post-dose. alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel. subjects should be supine for at least 5-10 minutes before the blood pressure and heart rate measurement.

Eligibility criteria:
inclusion criteria: * adult male subjects, * either 21 to 45 years of age, * must be medically healthy with no clinically significant screening results. exclusion criteria: * major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigator; systolic blood pressure \ 150 mmhg; diastolic blood pressure \ 95 mmhg; * allergy to or previous adverse events with pde5 inhibitors, alcohol or their constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome p450 3a4 enzyme within 30 days of day 1 dosing (period 1); * use of any investigational drug within 30 days of day 1 dosing (period 1); * use of any prescription or over-the-counter drugs or herbal remedies within 14 days of day 1 dosing (period 1); * history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol, positive cotinine test or positive urine drug screen at screening or on day -1; * positive serology for hiv, hcv, hbsag. additional exclusion criteria are listed in section 4.2.
adalimumab administered in korean rheumatoid arthritis subjects treated with methotrexate

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.


Eligibility criteria:
inclusion criteria: * meet acr criteria for diagnosis of active ra and have at \>6 swollen joints and \>9 tender joints * subjects must have received at least one prior dmard besides mtx, but may have had efficacy failures on no more than four standard dmards other than mtx * therapy with mtx for at least 6 months prior to screening and on a stable dose of mtx for at least 4 weeks prior to screening visit * age 18 years and older exclusion criteria: * prior treatment with any tnf antagonist, including adalimumab * history of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (tb), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin. * subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-cd4 antibody, within 6 months prior to the screening evaluation, prior treatment with any tnf antagonist, including adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide. * chest x-ray with calcified granuloma and/or pleural scarring * positive tb skin test, rt23 dose skin test, \>5 mm at 48 to 72 hours * unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition * intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation * female who is pregnant or breast-feeding.

Keywords: rheumatoid arthritis adalimumab
tele-rehabilitation in women with diastasis recti abdominis

Conditions: Diastasis Recti; Diastasis Recti and Weakness of the Linea Alba

Summary: the aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis. researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with dra.

diastasis of recti abdominis (dra) is defined as a separation of the two rectus abdominis muscles along the linea alba. increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. it is very common during pregnancy and may continue in the postnatal period. the loss of abdominal wall stability and weakened pelvic floor muscles may occur with dra. the abdominal wall is one of the key point for body posture, trunk and pelvic stability. the core stability exercises, pelvic floor training and trunk muscle trainings are some of the exercise regimes options for management of dra. however, in our best knowledge, there is no study in the literature that evaluates the effect of motor-control based telerehabilitation exercise program in women with dra.

Eligibility criteria:
inclusion criteria: * post- partum women (min 1 - max 5 years) exclusion criteria: * having a neurological, orthopedical or any other condition which affect postural stability.

Keywords: inter-recti distance postural control pelvic floor dysfunction body-self relation abdominal endurance
preliminary efficacy trial of a digital intervention for depression and cannabis use

Conditions: Depression - Major Depressive Disorder; Cannabis Use Disorder; Mental Disorder

Summary: the purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. participants will be randomized to complete amplification of positivity - cannabis use (amp-c) or symptom tracking. the main outcomes will include participant acceptability and usability ratings, completion rates and compliance, positive affect, substance use, and depression severity.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * resides in the united states * able to read and understand english and willing to provide informed consent/comply with the study protocol * moderate depressive symptom severity, as indicated by the patient health questionnaire-9 (phq-9) * problematic cannabis use, as indicated by the cannabis use disorder identification test - revised (cudit-r) * current elevated anhedonia, as indicated by the phq-9 * interest in receiving treatment for their cannabis use and/or depression * meet criteria for current mdd and cud per the dsm-5 exclusion criteria: * history of a psychotic disorder or bipolar disorder type i/ii * active suicidal ideation or intent based on the columbia-suicide severity rating scale * current psychotherapy engagement * changes in psychotropic medication within six weeks of the start of study
the effect of intra-abdominal pressure

Conditions: Diabetes Mellitus; ASA Triad; Cardiac Autonomic Neuropathy

Summary: the effect of intra-abdominal pressure

the effect of intra-abdominal pressure, applied to the patients diagnosed with diabetes mellitus, who undergo laparoscopic surgery, on hemodynamics

Eligibility criteria:
inclusion criteria: * diabetes mellitus * laparoscopic surgery exclusion criteria: * hypertension * hearth failure * renal failure * hepatic failure * difficult intubation * shock

Keywords: diabetes mellitus cardiac autonomic neuropathy laparoscopic surgery
does abstinence from e-cigarettes produce withdrawal symptoms?

Conditions: Substance Withdrawal Syndrome

Summary: the purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.

study design: the investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. the total study duration will be 14 days. participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. the investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance. every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an interactive voice response system. participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.

Eligibility criteria:
inclusion criteria: * 18 years or older * able to read and understand verbal english fluently * us citizen or resident alien * primarily uses e-cigarette product types of refillable tanks or modified devices * uses nicotine-containing e-liquid * has baseline urinary cotinine concentration of \> 100 ng/ml * has used e-cigarettes daily for the last 2 months * has a home or cell phone * agrees to abstain from tobacco, marijuana and other illegal drugs during study exclusion criteria: * smoked \> 5 tobacco cigarettes in the last month * used non-cigarette nicotine, tobacco or quit smoking products on \>5 days in the past month * use of cannabis (either marijuana or synthetic cannabis) \> 5 times in the past month or positive test for cannabis use at screening * current (last 6 months) generalized anxiety disorder, major depressive disorder, attention deficit hyperactivity disorder or moderate/severe substance abuse disorder * multiple legal, social health, work or school problems in the past month due to alcohol or drug use * pregnant or breastfeeding * previously a participant in the current study * use of prescribed or non-prescribed psychoactive medication \> 5 times in the past month * expired carbon monoxide level \> 8ppm

Keywords: abstinence abuse liability electronic cigarette e-cigarette electronic nicotine delivery device harm reduction nicotine nicotine dependence smoking smoking cessation tobacco vape vaping withdrawal
utility of severity scales in clinical practice in children hospitalized due to bronchiolitis.

Conditions: Bronchiolitis

Summary: prospective observational study of patients hospitalized with bronchiolitis. the objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.


Eligibility criteria:
inclusion criteria: children eligible for the trial must fulfil all of the following criteria: 1. children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms: * tachypnoea (who definition). * increased respiratory effort manifested as follows: 1. nasal flaring; 2. grunting; 3. use of accessory muscles; 4. intercostal and/or subcostal chest wall retractions; 5. apnoe. * crackles and/or wheezing. 2. aged 5 weeks - 24 months old. exclusion criteria: 1. diagnosis or suspicion of asthma.

Keywords: bronchiolitis bronchiolitis severity scoring validation utility
safety and efficacy of a sublingual specific immunotherapy with an extract of a six grass pollen mixture

Conditions: Grass Pollen Allergy

Summary: the trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture


Eligibility criteria:
inclusion criteria: rhinitis, rhinoconjunctivitis, positive rast result to grass pollen, positive skin prick test to grass pollen, positive specific provocation to grass pollen, exclusion criteria: serious chronic diseases, other perennial allergies

Keywords: sublingual immunotherapy rhinoconjunctivitis rhinitis asthma
tislelizumab in the systematic treatment of advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: study purpose: to evaluate the efficacy and safety of tislelizumab in combination with advanced hepatocellular carcinoma in the real world; study design: non-intervention, single center, case registration, real-world study; number of registrations: 40; source of data: this project is a non-interventionary real world case follow-up registration. all registration data are from real clinical practice cases. the collected data include the following requirements: 1. age ≥18 years old; 2. unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis; 3. plan or have received systemic therapy combined with tiralizumab; 4. no participation in other clinical studies; 5. access to tislelizumab treatment and other clinical records; primary endpoint: overall response rate; secondary endpoint: disease control rate, progress free survival, overall survival, safety; exploratory endpoint: to explore the predictive value of multiple biomarker combinations, such as pd-l1, tmb, msi, ddr, pole/pold, in hcc immunotherapy response.


Eligibility criteria:
this project is a non-interventionary real world case follow-up registration. all registration data are from real clinical practice cases. the collected data include the following requirements: 1. age ≥18 years old; 2. unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis; 3. plan or have received systemic therapy combined with tislelizumab; 4. no participation in other clinical studies; 5. access to tislelizumab treatment and other clinical records.
spatial frequency domain imaging (sfd) for assessment of diabetic foot ulcer development and healing

Conditions: Diabetic Foot Ulcer

Summary: this study is designed to evaluate the ability of spatial frequency domain imaging (sfdi) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers. the investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects


Eligibility criteria:
inclusion criteria: i. will be followed up in clinic on monthly basis for the next 12 months per standard of care ii. belong to one of the two target groups 1. subjects with an existing diabetic foot ulcer 2. subjects determined "at risk" for an ulcer exclusion criteria: 1. history of heart failure 2. rheumatoid arthritis 3. pregnant or lactating women
effects of reducing indoor air pollution on the adult asthmatic response

Conditions: Asthma

Summary: this study is about asthma and how the environment affects asthma. scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. this research is being done to study how the health of a person with asthma responds to an air cleaner. the investigator hypothesize that an air cleaner will improve the health of persons with asthma.

the investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. to this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in baltimore. participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). all participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.

Eligibility criteria:
inclusion criteria: * age 18-50 years of age * non-smoker (\<100 cigarettes in lifetime) * physician diagnosis of asthma * symptoms of asthma and/or reliever medication use in the past 6 months * living in the current residence \>= 6 months within baltimore * enrollment in, and completion of, the observational environmental asthma study "inhale 1" exclusion criteria: * current diagnosis of another major pulmonary disease, other significant morbidity * pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential) * planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period * current use of an air cleaner in the home

Keywords: asthma hepa air pollutants lung function home environment respiratory symptoms
usefulness of 18f-fdg pet/ct in the initial staging and surveillance of endometrial cancer patients

Conditions: Endometrial Cancer

Summary: 1. to assess the value of 18f-fdg pet/ct in the initial staging and detection of recurrent cases of endometrial cancer. 2. to determine correlation between pet/ct derived parameters including suvmax, tlg and mtv and clinic-pathological patient characteristics. 3. to detect local and distant recurrence after therapy.

endometrial cancer (ec) is one of the most common gynaecological malignancies worldwide.the incidence rate of uterine cancer in egypt was 4.1 per 100,000. the standard surgery consists of laparotomy, hysterectomy, and bilateral salpingo-oophorectomy. maximal surgical cytoreduction is recommended for advanced ec. prognostic impact of complete lymphadenectomy remains controversial, especially in early- stage disease. with the aim of predicting extrauterine disease pre-operatively and optimizing surgical planning, several techniques have been evaluated, including 18f-fluoro-2-deoxyglucose (18f-fdg) positron emission tomography/computed tomography (pet/ct). pet /ct can be used to effectively and accurately diagnose ec pelvic lymph node metastasis and distant metastasis. it has great value in clinical staging, judging prognosis, diagnosing recurrence. radiomics analysis of the uterine primary tumor on pre-operative 18f-fdg pet images may help predict the presence of metastatic nodes, thus reducing false-negative results and increasing the sensitivity of the technique. the maximum standard uptake value (suvmax), metabolic tumor volume (mtv) and total glycolysis (tlg) of primary lesions are significantly correlated with pathological tissue grading. previous studies on metabolic parameters of primary lesions examined by 18f-fdg pet/ct for endometrial cancer mainly focused on suvmax, however, suvmax can only reflect the functional metabolic degree of the point. it cannot assess the overall metabolic situation of tumor. mtv and tlg can more comprehensively measure the glucose metabolic activity of tumor cells with more clinical value in reflecting the malignancy degree of tumor.

Eligibility criteria:
inclusion criteria: * patients proved to have endometrial cancer by curettage or hysteroscopy. * patients accepted surgery treatment, without anti-tumor and hormone therapy before surgery. * ability to stay still for the duration of the pet/ct scan (\~15 minutes). * ability of the patient (or his/her guardian) to sign informed consent. exclusion criteria: * patients who recieved neoadjuvant therapy before pet/ct. * patients with tumors other than endometrial cancer. * pregnancy. * inability to give informed consent. * inability to stay still for the duration of the scan. * claustrophobia